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July 3, 2008

Vol. 2 No. 27

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CDRH Pushing Industry on PMAP Inspections

Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director. Read More

Surgical Tools Sterilized in Hydraulic Waste Result in Suit

Devicemakers Steris and Cardinal Health are facing a class action lawsuit after surgical instruments at two hospitals were sterilized in hydraulic waste fluid from elevators rather than Steris cleaning solutions. Read More

FDA’s Sentinel Initiative Will Not Burden Industry

The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance, will likely not place additional regulatory burdens on devicemakers, according to an agency director. Read More

Bayer Acquires Topsun Portfolio

Bayer HealthCare (BHC) announced that BHC's Consumer Care Division has achieved the necessary regulatory approvals to complete the acquisition of the Western over-the-counter (OTC) cough and cold portfolio of Topsun Science and Technology Qidong Gaitianli Pharmaceutical Co., Ltd by Bayer Healthcare Company Limited in China. Read More

Progen Pharmaceutical Manufacturing Arm to Stand Alone

Brisbane-based Progen Pharmaceuticals Limited announced the "spin-out" of its manufacturing business as the wholly owned subsidiary company PharmaSynth Pty Ltd. Read More

Cantel Medical to Move Dutch Operations to U.S.

Cantel Medical, a provider of infection-prevention products, said its Minntech Corp. subsidiary will move all of its Dutch manufacturing operations to the United States. Read More

55 New Jobs Coming to North Carolina

A Virginia-based pharmaceutical company is opening a plant, creating 55 new jobs. Galexe Pharma Sciences, a subsidiary of Excela PharmSci Inc., is investing $8.6 million in the plant over the next three years. Read More

CytoDyn Begins GMP Manufacturing of AIDS Drug

CytoDyn has begun GMP manufacturing and humanization of Cytolin, a monoclonal antibody that uses the human immune system to control HIV infection. Read More

Breakthrough Imtech in Belgian Pharmaceutical Market

Imtech will realise much of the technology in the CDPP project (Chemical Development Pilot Plant) in Geel for Janssen Pharmaceutica (part of the American pharmaceutical group Johnson & Johnson). Read More